Table 4.
Bioequivalence Statistics for PK Parameters of LZM003 and Reference Drug–BEAS
|
PK Variables (N = 47) |
LSM and GMR | 90% CI | ANOVA P value | CV (%) | Power (%) | ||||
|---|---|---|---|---|---|---|---|---|---|
| LZM003 | Reference Drug | LZM003/Reference Drug | Formulations | Sequence | Period | ||||
| AUC0-∞ (hr*ng/mL)a | 5.7442 | 5.7701 | 0.9745 | (0.9144, 1.0385) | 0.4981 | 0.7299 | 0.5735 | 18.5 | 100 |
| AUC0–t (hr*ng/mL) | 5.6764 | 5.6993 | 0.9774 | (0.9221, 1.0360) | 0.5122 | 0.8226 | 0.9365 | 16.9 | 100 |
| Cmax (ng/mL) | 1.8061 | 1.7216 | 1.0882 | (0.9998, 1.1845) | 0.1008 | 0.8980 | 0.2266 | 24.8 | 86 |
| Tmax (hr)a | - | - | −2.000 | (−4.000, 0.000) | 0.2387 | 0.1962 | 0.6928 | - | - |
| t1/2 (hr)a | - | - | −8.940 | (−11.918, −5.963) | <0.0001 | 0.7178 | 0.0255 | - | - |
Notes: aThe median of Tmax and t1/2 were analyzed by the nonparametric method.
Abbreviations: BEAS, bioequivalence analysis set; AUC0-∞, the area under the curve between 0 and infinity; AUC0–t, the area under the curve of the plasma concentration until the last concentration observed; Cmax, the peak of concentration; Tmax, time to Cmax; t1/2, terminal elimination half-life; ANOVA, analysis of variance; LSM, least-square mean; GMR, geometric mean ratio; CI, confidence interval; CV, coefficient of variation.